Regulatory types like documentation. You have already applied several techniques to your design process that were intended to assure the requested level of functionality. You claim to use only documented APIs, do not depend upon OS internal structures, and have tested a wide variety of actual hardware. The first thing you should do for the regulatory people is to write down this list of things you've already done. Next you should make a list of things that could go wrong, both things you control and, more importantly, things you do not control.
As a technical problem, you can only be held accountable for your own efforts. If you wish to act as an insurance business, you can accept the responsibility for what others (like Palm) do, even though you have no control over their actions. The highest quality software that I've seen was written by one individual/group, and studied by another. The function of the second pass over the code was solely to audit it. Done right, this is a valuable process for everyone. Done wrong, it can be a nit picking argument over the spelling of comments, indentation style, and other aspects of a program that do not relate to the externally visible function. Another technique I've seen used effectively is what I call grooming. Code is revised to improve coherency, without necessarily changing the actual results. I'm much more impressed by the results of code audits than by the results of black box testing. The quality of the code needs to be matched to the quality requirements of its application. Code that controls medical life support devices clearly needs more attention than game or entertainment software. You need to understand the value system of those imposing the regulations. Are they trying to assure a level of quality, or simply on an ego trip to demonstrate their ability to control you? If they really want quality, demonstrate that you consider them a valuable part of your team. If they're just SOBs, flood them with details that they will have to wade through. -- For information on using the Palm Developer Forums, or to unsubscribe, please see http://www.palmos.com/dev/support/forums/
